Catalog Number

H40342LZ

Brand Name

Micro-Touch® Stabilizer

Version/Model Number

H40342LZ

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 07, 2022

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K131161

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

e9c2fdaa-023a-4509-afc0-9034e5eac12b

Public Version Date

August 23, 2022

Public Version Number

5

DI Record Publish Date

August 22, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-